FDAHealthMarch 17, 2025
BIOCON PHARMA INC — Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT,
⚠️ Failed dissolution specifications: lower than specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 17, 2025
U.S.A. nationwide
What's affected?
- Product
- Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
- Brand
- ATORVASTATIN CALCIUM
- UPC
- 0370377080111
- Lot code
- AVC24035
Additional details
Lot#: AVC24035, Exp 03/31/26
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2184 bottles.
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